FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM

K051802 · Abbott Diabetes Care, Inc. · NBW · Aug 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051802
• Device Name: FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Connect Blood Glucose Monitoring System is intended for invitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Story

The FreeStyle Connect Blood Glucose Monitoring System is a portable device for quantitative glucose measurement. It utilizes coulometric biosensor technology via test strips containing glucose dehydrogenase (GDH) enzyme. The system accepts fresh capillary, venous, arterial, or neonatal whole blood samples. The device measures glucose electrochemically; the biosensor recognizes glucose in the sample, producing an electrical signal proportional to the glucose concentration. Used in home and professional clinical settings by patients or healthcare providers. The output is a numerical blood glucose level displayed on the monitor, which assists in monitoring glucose levels and clinical decision-making.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of modified device with new sensing strip.

Technological Characteristics

Glucose monitoring system utilizing electrochemical sensing strips. Modification limited to integration of sensing strip cleared in K050500. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh capillary, venous, arterial, and neonatal whole blood samples. For in vitro diagnostic use in home and professional settings.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Precision PCx Blood Glucose Monitor (K022941)
• FreeStyle 600 Blood Glucose Test Strips (K050500)

Submission Summary (Full Text)

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K05/802

Image /page/0/Picture/1 description: The image shows the word "ABBOTT" with a stylized "a" to the left of the word. The word is written in a simple, sans-serif font. The stylized "a" is a geometric shape that resembles a lowercase "a" but is made up of straight lines and sharp angles.

AUG 9 - 2005

Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

Telephone [phone] Facsimile 510-239-2799 www.abbott.com

## 510(k) Summary

Per 21 CFR §807.92

| Company | Abbott Laboratories / TheraSense Inc. |
|------------------------|------------------------------------------------------------------------------------|
| Division | Abbott Diabetes Care |
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Phone | 510-749-5400 |
| Contact Person: | Kimberley Kline<br>510-749-5478<br>[e-mail] |
| Proprietary Name: | FreeStyle Connect™ Blood Glucose Monitoring<br>System |
| Common Name: | Blood Glucose Meter and Reagent Test Strips |
| Classification Number: | 21 CFR §862.1345 |
| Predicate Device: | Precision PCx Blood Glucose Monitor and<br>FreeStyle 600 Blood Glucose Test Strips |
| Date Prepared: | June 30, 2005 |

#### Description of the Device:

The FreeStyle Connect monitor utilizes coulometric biosensor technology found in the FreeStyle Connect test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Connect BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.

#### Intended Use of the Device:

The FreeStyle Connect Blood Glucose Monitoring System is intended for invitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

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Image /page/1/Picture/0 description: The image shows the word "ABBOTT" in a bold, sans-serif font. To the left of the word is a stylized "a" symbol, also in bold. The text and symbol are black against a white background.

| | Predicate Devices | Subject (modified)<br>Device |
|------------------------|---------------------------------------------------------------------------------------|------------------------------|
| Company | Abbott Laboratories | Same |
| Division | Abbott Diabetes Care | Same |
| 510(k) Reference | K022941 and K050500 | Current Submission |
| Proprietary Name: | Precision PCx Point of Care Monitor<br>and FreeStyle 600 Blood Glucose Test<br>Strips | Same |
| Common Name: | Blood Glucose Monitor and Reagent<br>Test Strips | Same |
| Classification Number: | 21 CFR §862.1345 | Same |
| Intended Use | Quantitative measurement of blood<br>glucose concentrations | Same |
| Single Use? | Yes, test strips are single use | Same |
| Sterilized? | No | Same |

# Comparison to Predicate Device:

# Performance Studies:

The performance of the FreeStyle Connect BGMS was studied in the laboratory. The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices.

## Conclusion:

Results of laboratory testing demonstrated that the performance of the FreeStyle Connect BGMS is acceptable and comparable to the performance of the predicate devices for blood glucose testing when used according to its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly Kline Senior Regulatory Associate Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

AUG 9 - 2005

Re: k051802

Trade/Device Name: FreeStyle Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 29, 2005 Received: August 1, 2005

Dear Ms. Kline:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must cormply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Satz

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

FreeStyle Connect™ Blood Glucose Monitoring System Device Name:

Indications for Use:

The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter × Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

C

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k051802

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